Exelixis said it will pursue a New Drug Application following Phase 3 STELLAR-303 results showing its oral TKI zanzalintinib plus atezolizumab reduced risk of death by about 20% versus regorafenib in previously treated non–MSI-high metastatic colorectal cancer. The intent-to-treat median overall survival extended to 10.9 months versus 9.4 months with the comparator; the company plans regulatory filings later this year. Presentations at ESMO and publication in The Lancet provided the detailed dataset; investigators and Exelixis flagged a higher rate of grade 3–4 adverse events consistent with TKI–ICI combinations. Exelixis positions zanzalintinib as a potential franchise molecule in GI oncology while investors evaluate the tradeoff between efficacy and tolerability.